Mike Gerometta has been Head of Chemistry, Manufacturing & Controls (CMC) Development for Opthea since 2008 with responsibilities encompassing outsourcing of Opthea’s biopharmaceutical research and cGMP manufacturing activities for its therapeutic and diagnostic portfolio, as well as oversight of internal laboratory activities.
Mike has over 30 years’ experience in the Australian biotechnology industry, most recently as Chief Operating Officer of Q-Gen, the manufacturing facility of the Queensland Institute of Medical Research. He has extensive experience working with numerous Contract Manufacturing Organisations overseas and locally in all facets of translational CMC from concept through to Phase II studies, in the process successfully guiding the manufacture of five biologics through to Phase 1/2 clinical trials, including oversight of two nonclinical programs, as well as associated regulatory interactions in North America, Europe and Australia.
He has also directed the development of numerous in vitro diagnostic products through to the market over 19 years at Amgen Biomedical, ultimately as Research and Product Development Director. Mike was awarded his PhD in biotechnology from the Queensland University of Technology and has a degree in chemistry from the University of Technology in Sydney.